Clinical Trials Assistant

Job description

Job responsibilities

PRIMARY DUTIES & AREAS OF RESPONSIBILITY

Patient support

To assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the co-ordination of pre-study tests, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols

To assist the co-ordination of the patients journey through the clinical trial protocol e.g. requisition and organisation of any necessary investigations, procurement of patient notes and X-Rays.

Team Working

To ensure that all members of the multidisciplinary team are aware of the current trials portfolio.

To assist with providing feedback to specific research teams and MDT members on issues relating to recruitment, protocol amendments and trial results.

To disseminate information from the NIHR, trial co-ordinators to the local research teams

The post holder will demonstrate the ability to manage their own administrative case-load, working as part of the multidisciplinary team.

In conjunction with all members of the clinical trial teams and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service.

Administration

To assist the Senior Research Midwives and Research Midwives and Nurse in the formulation of documentation in preparation for ethical submission.

To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.

To ensure that all toxicity, quality of life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments.

To ensure that all trial data is submitted to the study sponsor within the specified time constraints.

To manage and respond to any data queries received as directed by Research Team.

To maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs

To report accrual data on all patients recruited onto the recruitment data base e.g. EDGE.

General

To provide administrative support for research midwives and nurse as required by the research teams across the Trust e.g. send letters and faxes, collecting and returning medical notes, taking and disseminating minutes of meetings

To help implement local and national quality standards, professional standards, recommendations and guidelines from national reports.

Ensure that office and clinic supplies are adequately ordered and stored for the smooth running of the trials.

The post holder will adhere to the Data Protection Act and maintain patient confidentiality at all times.

The post holder will act in a professional manner at all times when dealing with patients, their relatives and representatives from both external and internal sources.

The post holder will deal with telephone enquiries from staff, patients and carers ensuring that appropriate personnel are informed in order for actions to be taken.

The post holder will be expected to represent the Trust in a professional manner at meetings and events, as required.

The post holder will be expected to work to ICH/GCP guidelines at all times.

As a new post holder, an induction and training programme will be provided for key aspects of this role. The post holder will be expected to take advantage of opportunities to attend meetings and workshops to enhance their knowledge of Clinical Research.

Ensure that (s)he follows the Trusts hospital infection prevention and control policies and procedures to protect patients, staff and visitors from healthcare-associated infections. He or she will ensure that (s)he performs the correct hand hygiene procedures, when entering clinical areas.

Undertake any other duties appropriate to the role.

Person Specification

Qualifications

Essential

• Good standard of education to a minimum of GCSE level
• NVQ level 3 in Business Administration (or equivalent experience)*

Knowledge

Essential

• A willingness to undergo personal development and learn new skills
• Knowledge of research methodologies

Desirable

• Previous GCP training

Skills

Essential

• IT skills including use of Microsoft word, outlook and excel
• Able to work on own initiative/Proactive approach
• Ability to support and educate colleagues, patients and carers
• Able to prioritise and manage time effectively

Experience

Essential

• Previous administrative experience

Desirable

• Clinical Trials experience

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Bradford Teaching Hospitals NHS Foundation Trust

Address

Bradford Teaching Hospitals

Bradford

BD9 6RJ

Employer's website

https://www.bradfordhospitals.nhs.uk (Opens in a new tab)